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Biodefense

Public Health Emergencies.

Provide candidate therapeutics emergency use services in P2 and P3 laboratories

Decouvor collaborates with multiple globally licensed biological laboratories to develop candidate therapeutics for medical responses to bioterrorism, including those targeting Bacillus anthracis and Yersinia pestis. We offer biosafety level BSL-2 (P2) and BSL-3 (P3) laboratory services.

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Animal Models

Diverse Preclinical Animal Models

Provide services for Syrian hamsters, hACE2 mice, and non-human primate models

Decouvor collaborates with multiple globally licensed biological laboratories to conduct preclinical experiments in biosafety level BSL-2 (P2) and BSL-3 (P3) laboratories. We develop experimental protocols, optimize candidate drug formulations, comply with regulatory requirements, actively communicate with regulatory agencies, and provide biological data that meets these requirements. Our services include enzyme-linked immunosorbent assays (ELISA), assessment of cytokine expression for biomarkers, immunogenicity testing, qPCR and RT-qPCR testing, immunological assays, and inhalation toxicology studies.
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Gene Therapy

Preclinical Research

Preclinical Research On Gene Therapy

The regulatory guidelines for the toxicology and safety pharmacology studies necessary for advancing gene therapy into human clinical trials are continuously evolving. Unlike other therapeutic categories, such as small molecules or biologics, the preclinical research requirements for gene therapy are tailored to the specific characteristics of the therapy. Furthermore, gene therapy encompasses a variety of approaches, including in vitro gene editing and in vivo viral and non-viral vector therapies.
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Pharmacokinetics

Preclinical Research and Development

Pharmacokinetic Studies

We provide comprehensive non-GLP pharmacokinetic research solutions, including rapid turnaround pharmacokinetic screening for early optimization and formulation evaluation, as well as complete pharmacokinetic programs that encompass lifespan studies, bioanalysis, and pharmacokinetic modeling. Studies can be conducted in both rodent and non-rodent species, including ferrets, dogs, mini pigs, and non-human primates.

We offer in vivo pharmacokinetic study services, including:
  • Bioavailability
  • Biodistribution and Bioequivalence
  • In Vivo ADME (Absorption, Distribution, Metabolism, and Excretion).
  • PK/PD
  • Studies Using Radiolabeled Drugs
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Medical Devices

Medical Devices

FDA Medical Device Application Services

Decouvor provides comprehensive application services for in vitro and in vivo medical devices, including 510(k), PMA, De Novo, and 513(g) submissions. We establish medical device equivalence documentation to support regulatory requirements.

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Immunology Research

Oncology Pharmaceuticals

Immuno-oncology research assays

Conduct research on tumor inhibitors, cancer vaccines, oncolytic viral vectors, and adoptive T cell immunotherapy to modulate tumor immune responses. Advance new drug candidates to clinical trials through preclinical studies.

We provide immuno-oncology research services, including:

  • In vitro and in vivo T cell depletion models
  • Cytokine panels
  • ELISpot assays
  • Multicolor FACS for immune phenotyping
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Reliable ServicesProvide services that meet regulatory agency requirements

Testing, researching, developing, and improving products to seek better, safer, and more convenient options

Exploration in Novel Drug

Early-stage exploration of drug candidates, with literature and data support, IP strategy optimization, and preclinical feasibility and risk analysis.

Preclinical Pharmaceutical Research

Adhering to regulatory compliance requirements, we develop rational preclinical pharmaceutical research strategies with a focus on the long-term development of drug candidates, providing specialized analysis and research solutions.

Biodefense Research

In collaboration with multiple global biosafety laboratories at BSL-2 (P2) and BSL-3 (P3) levels, we provide GLP-compliant pharmacodynamic ABSL-3+ (P3+) animal biosafety experimental services.

Medical Device 510(k)

In accordance with the current manufacturing conditions of medical device companies and the FDA 510(k) application principles, we offer comprehensive, tailored guidance and solutions.

From laboratory-based drug discovery and exploration to advancing drug candidates into clinical trials, the process is complex and requires comprehensive, multidisciplinary professional services. Decouvor’s experienced team of experts, including immunologists, pathologists, toxicologists, analytical chemists, cancer biologists, molecular biologists, infectious disease scientists, and biopolymer specialists, collaborates with you to develop precise strategies for new drug development and preclinical research. We aim to efficiently advance drug candidates into clinical trials at the most reasonable cost.

Accreditation and Registration

Decouvor's global partners and laboratories have received accreditation and registration

  • European Certificate of GMP Compliance
  • Food and Drug Administration (FDA)
  • International Standards Organization (ISO9001 and ISO17025)
  • ISO 9001
  • United States Department of Agriculture (USDA)
  • ISO 17025
  • ISTA Testing Laboratory

Vaccine R&D

Vaccine Development Research

Establish a vaccine development roadmap and quantify CMC (Chemistry, Manufacturing, and Controls) data

Develop the technological foundation for vaccines, including high mRNA, DNA, adenovirus, and polymer vaccine technology pathways. Refine CMC production technology requirements, quantify antigen and adjuvant ratios, and optimize the structure of stabilizers, preservatives, and surfactants. Provide regulatory agencies with comprehensive efficacy studies and toxicological analyses.

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Toxicological Research

Pharmacological Toxicology

Toxicology Research and Drug Selection Following Regulatory Agency Guidelines.

Data on in vitro metabolism and plasma protein binding in animals and humans, as well as repeated-dose toxicity study data (ICH S3A), should typically be evaluated before initiating human clinical trials. Before exposing a large number of human subjects or conducting long-term treatments (usually prior to Phase I), more information regarding the pharmacokinetics (PK) of the test species (such as absorption, distribution, metabolism, and excretion) should be obtained, along with in vitro biochemical information related to potential drug interactions. This data can be used to compare metabolites between humans and animals and to determine whether any additional testing is necessary.

 

We provide acute and chronic toxicity study services, including:

  • Respiratory Rate, Tidal Volume, and Minute Volume.
  • Maximum Tolerated Dose (MTD)
  • Dose Range Finding Study (DRF)
  • Acute, Subchronic, and Chronic Toxicity Studies
  • Repeated Dose Toxicity Studies
  • Reproductive Toxicology
  • Carcinogenicity Studies
  • 2-Year and 6-Month Transgenic Studies
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      +1 (202) 599 6688
      info@decouvor.com
      40 Lloyd Ave Ste 203 Malvern, PA, 19355.USA

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